Sclerotic DentineNCT05211908
Clinical Performance of Different Adhesive Strategies With a Universal System in Sclerosed Dentin in NCCL: A Double-blind Randomized Clinical Trial.
A study testing Composite resin restoration with Self Etch adhesive protocol and absence of sclerotic dentin, Composite resin restoration with Seletive enamel etch adhesive protocol and absence of sclerotic dentin and Composite resin restoration with Self Etch adhesive protocol and presence of sclerotic dentin in people with Sclerotic Dentine and Non Carious Cervical Lesion, run by Universidade Federal do Para at 1 site in Brazil.
Trial summary
The aim of this randomized, prospective, parallel, double-blind clinical trial will be to evaluate the clinical performance of restorations performed in non-carious cervical lesions (NCCL) using a soft ph universal adhesive system, varying the adhesive strategy (self-etching vs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sclerotic Dentine, Non Carious Cervical Lesion
- What is being tested?
- Composite resin restoration with Self Etch adhesive protocol and absence of sclerotic dentin, Composite resin restoration with Seletive enamel etch adhesive protocol and absence of sclerotic dentin and Composite resin restoration with Self Etch adhesive protocol and presence of sclerotic dentin
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Jul 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good general health status
- Good oral hygiene
- Absence of periodontal disease
- Minimum of 20 teeth in occlusion
- Presence at least one (01) non-carious cervical lesion in a tooth with pulp vitality.
- Non-carious cervical lesion greater than 1mm in depth.
- Non-carious cervical lesion involving enamel and dentin.
Who cannot join
- Non- carious cervical lesion cavo surface margin involving more than 50% of the enamel.
- NCCL in crack teeth.
- Absence of opposing teeth and/or adjacent to the lesion.
- Presence of occlusal trauma in the NCCL tooth
- Presence of orthodontic appliance or removable partial denture with retention in the tooth where the lesion is located
- Patients that underwent tooth whitening procedures within a period of less than 14 days from the date of restoration
Show all 11Show fewer
- Patients with high risk of caries (presence of three or more active caries lesions)
- Xerostomia
- Bruxism
- Pregnant women
- Patients who do not accept the study conditions
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal do Pará
Belém, Pará
Cecy M Silva, PhD, (91)32017563 ext. 55, cecymsilva@gmail.com
About this study
The aim of this randomized, prospective, parallel, double-blind clinical trial will be to evaluate the clinical performance of restorations performed in non-carious cervical lesions (NCCL) using a soft ph universal adhesive system, varying the adhesive strategy (self-etching vs. selective etching of the enamel) and the sclerosis characteristics of the dentinal substrate over 24 months.
Read the detailed description
Two hundred restorations will be performed in NCCL of volunteers of both genders, by a single operator, using the Single Bond Universal(3M ESPE) adhesive system. The restorations will be randomly allocated into 4 groups (n-50): D-SE (absence of dentinal sclerosis and self-etching protocol); D-SELETIVE (absence of dentinal sclerosis and selective enamel etching protocol); SD-SE (sclerotic dentin and self-etching protocol); SD-SELETIVE (sclerotic dentin and selective enamel etching protocol). The randomization process within subject was performed by computer-generated tables by a staff member not involved in the research protocol. Details of the allocated group were recorded on cards contained in sequentially numbered, opaque, sealed envelopes. These were prepared by a staff member who was not involved in any of the phases of the clinical trial. The allocation assignment was revealed by opening the envelope on the day of the restorative procedure.The operator was not blinded to group assignment when administering.
The evaluations of the clinical performance of the restorations will be carried out by two previously calibrated examiners, adopting the criteria of the United States Public Health Service (USPHS) for the variables retention, marginal adaptation, marginal staining and postoperative sensitivity . The intragroup statistical analysis will be performed using the McNemar test for the variables retention and postoperative sensitivity; and by Wilcoxon for adaptation and marginal staining. To compare the clinical performance inter groups in the different assessment intervals, Fisher's exact test (retention and postoperative sensitivity) and Kruskal-Wallis (adaptation and marginal staining) will be used.
- Conditions
- Sclerotic Dentine, Non Carious Cervical Lesion
- Being tested
- Composite resin restoration with Self Etch adhesive protocol and absence of sclerotic dentin, Composite resin restoration with Seletive enamel etch adhesive protocol and absence of sclerotic dentin, Composite resin restoration with Self Etch adhesive protocol and presence of sclerotic dentin, Composite resin restoration with Seletive enamel etch adhesive protocol and presence of sclerotic dentin
- Keywords
- adhesives, dental bonding
- Medical subject headings
- Dentin, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composite resin restoration with Self Etch adhesive protocol and absence of sclerotic dentinProcedure or surgery
The adhesive system Single Bond Universal (3M Oral Care; Brazil) and a nanoparticulate composite resin Z350 XT (3M Oral Care; Brazil), shade A3B, will be the materials used in the restorative procedures.
For the D-SE group, the universal adhesive system will be applied with a disposable microbrush, actively, for 20s and then a gentle stream of air will be used for 5s to solvent evaporation, followed by light curing for 10s using the Valo Cordless light curing (Ultradent Products Inc.), in Standard mode (1000mW /cm2).
All groups will receive the restorations made following the incremental technique of insertion of composite resin (2mm per increment), which will be light cured according to the manufacturer's recommendations.
Composite resin restoration with Seletive enamel etch adhesive protocol and absence of sclerotic dentinProcedure or surgery
The adhesive system Single Bond Universal (3M Oral Care; Brazil) and a nanoparticulate composite resin Z350 XT (3M Oral Care; Brazil), shade A3B, will be the materials used in the restorative procedures.
For the D-SELETIVE group a 37% phosphoric acid will be applied only at the enamel margin for 15s, then rinsed with water for 20s, and slightly dry. The universal adhesive system will be applied with a disposable microbrush, actively, for 20s and then a gentle stream of air will be used for 5s to solvent evaporation, followed by light curing for 10s using the Valo Cordless light curing (Ultradent Products Inc.), in Standard mode (1000mW /cm2).
All groups will receive the restorations made following the incremental technique of insertion of composite resin (2mm per increment), which will be light cured according to the manufacturer's recommendations.
Composite resin restoration with Self Etch adhesive protocol and presence of sclerotic dentinProcedure or surgery
The adhesive system Single Bond Universal (3M Oral Care; Brazil) and a nanoparticulate composite resin Z350 XT (3M Oral Care; Brazil), shade A3B, will be the materials used in the restorative procedures.
For the SD-SE group, the universal adhesive system will be applied with a disposable microbrush, actively, for 20s and then a gentle stream of air will be used for 5s to solvent evaporation, followed by light curing for 10s using the Valo Cordless light curing (Ultradent Products Inc.), in Standard mode (1000mW /cm2).
All groups will receive the restorations made following the incremental technique of insertion of composite resin (2mm per increment), which will be light cured according to the manufacturer's recommendations.
Composite resin restoration with Seletive enamel etch adhesive protocol and presence of sclerotic dentinProcedure or surgery
The adhesive system Single Bond Universal (3M Oral Care; Brazil) and a nanoparticulate composite resin Z350 XT (3M Oral Care; Brazil), shade A3B, will be the materials used in the restorative procedures.
For the SD-SELETIVE group a 37% phosphoric acid will be applied only at the enamel margin for 15s, then rinsed with water for 20s, and slightly dry. The universal adhesive system will be applied with a disposable microbrush, actively, for 20s and then a gentle stream of air will be used for 5s to solvent evaporation, followed by light curing for 10s using the Valo Cordless light curing (Ultradent Products Inc.), in Standard mode (1000mW /cm2).
All groups will receive the restorations made following the incremental technique of insertion of composite resin (2mm per increment), which will be light cured according to the manufacturer's recommendations.
| Study group | Role | What they receive |
|---|---|---|
| D-SE | Experimental | Absence of dentinal sclerosis and self-etching adhesive protocol Receives: Procedure: Composite resin restoration with Self Etch adhesive protocol and absence of sclerotic dentin |
| D-SELETIVE | Active comparator | Absence of dentinal sclerosis and selective enamel etching adhesive protocol Receives: Procedure: Composite resin restoration with Seletive enamel etch adhesive protocol and absence of sclerotic dentin |
| SD-SE | Experimental | Sclerotic dentin and self-etching adhesive protocol Receives: Procedure: Composite resin restoration with Self Etch adhesive protocol and presence of sclerotic dentin |
| SD-SELETIVE | Experimental | Sclerotic dentin and selective enamel etching adhesive protocol Receives: Procedure: Composite resin restoration with Seletive enamel etch adhesive protocol and presence of sclerotic dentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
The restorations retention will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores:
Alpha - retained Bravo - partially retained Charlie - restoration lost For evaluation of clinical performance, beta and charlie scores will be considered as failure.
Measured: 1 year
Retention
The restorations retention will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores:
Alpha - retained Bravo - partially retained Charlie - restoration lost For evaluation of clinical performance, beta and charlie scores will be considered as failure.
Measured: 2 years
Secondary outcomes (4)
Marginal adaptation
Marginal adaptation will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores:
Alpha - Restoration is continuous with existing anatomic form. Bravo - Detectable V-shaped defect in enamel only. Catches explorer going both ways Charlie - Detectable V-shaped defect to dentin-enamel junction
Measured: 1 year
Marginal adaptation
Marginal adaptation will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores:
Alpha - Restoration is continuous with existing anatomic form. Bravo - Detectable V-shaped defect in enamel only. Catches explorer going both ways Charlie - Detectable V-shaped defect to dentin-enamel junction
Measured: 2 years
Marginal staining
Marginal staining will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores:
Alpha - No discoloration along the margin Bravo - Slight and superficial staining (removable, usually localized). Charlie - Deep staining cannot be polished away
Measured: 1 Year
Marginal staining
Marginal staining will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores:
Alpha - No discoloration along the margin Bravo - Slight and superficial staining (removable, usually localized). Charlie - Deep staining cannot be polished away
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start27 Jul 2021
- Primary completion30 Mar 2022
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sclerotic DentineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Para
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecy Martins Silva, Universidade Federal do Para
- Investigators
- Cecy M Silva, PhD, Principal investigator, Universidade Federal do Pará
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211908
- Sponsor's protocol ID
- UFPara-0013
- Status last verified
- May 2022
- First submitted
- 13 Jan 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Different Adhesive Strategies With a Universal System in Sclerosed Dentin in NCCL: A Double-blind Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05211908
- Acronym / sponsor ID
- UFPara-0013
- Conditions
- Sclerotic Dentine, Non Carious Cervical Lesion
- Keywords
- adhesives, dental bonding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized, prospective, parallel, double-blind clinical trial will be to evaluate the clinical performance of restorations performed in non-carious cervical lesions (NCCL) using a soft ph universal adhesive system, varying the adhesive strategy (self-etching vs. selective etching of the enamel) and the sclerosis characteristics of the dentinal substrate over 24 months.
Detailed description
Two hundred restorations will be performed in NCCL of volunteers of both genders, by a single operator, using the Single Bond Universal(3M ESPE) adhesive system. The restorations will be randomly allocated into 4 groups (n-50): D-SE (absence of dentinal sclerosis and self-etching protocol); D-SELETIVE (absence of dentinal sclerosis and selective enamel etching protocol); SD-SE (sclerotic dentin and self-etching protocol); SD-SELETIVE (sclerotic dentin and selective enamel etching protocol). The randomization process within subject was performed by computer-generated tables by a staff member not involved in the research protocol. Details of the allocated group were recorded on cards contained in sequentially numbered, opaque, sealed envelopes. These were prepared by a staff member who was not involved in any of the phases of the clinical trial. The allocation assignment was revealed by opening the envelope on the day of the restorative procedure.The operator was not blinded to group assignment when administering.
The evaluations of the clinical performance of the restorations will be carried out by two previously calibrated examiners, adopting the criteria of the United States Public Health Service (USPHS) for the variables retention, marginal adaptation, marginal staining and postoperative sensitivity . The intragroup statistical analysis will be performed using the McNemar test for the variables retention and postoperative sensitivity; and by Wilcoxon for adaptation and marginal staining. To compare the clinical performance inter groups in the different assessment intervals, Fisher's exact test (retention and postoperative sensitivity) and Kruskal-Wallis (adaptation and marginal staining) will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| D-SE | Experimental | Procedure: Composite resin restoration with Self Etch adhesive protocol and absence of sclerotic dentinAbsence of dentinal sclerosis and self-etching adhesive protocol |
| D-SELETIVE | Active comparator | Procedure: Composite resin restoration with Seletive enamel etch adhesive protocol and absence of sclerotic dentinAbsence of dentinal sclerosis and selective enamel etching adhesive protocol |
| SD-SE | Experimental | Procedure: Composite resin restoration with Self Etch adhesive protocol and presence of sclerotic dentinSclerotic dentin and self-etching adhesive protocol |
| SD-SELETIVE | Experimental | Procedure: Composite resin restoration with Seletive enamel etch adhesive protocol and presence of sclerotic dentinSclerotic dentin and selective enamel etching adhesive protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Good general health status
- Good oral hygiene
- Absence of periodontal disease
- Minimum of 20 teeth in occlusion
- Presence at least one (01) non-carious cervical lesion in a tooth with pulp vitality.
Key exclusion criteria (11 listed)
- Non- carious cervical lesion cavo surface margin involving more than 50% of the enamel.
- NCCL in crack teeth.
- Absence of opposing teeth and/or adjacent to the lesion.
- Presence of occlusal trauma in the NCCL tooth
- Presence of orthodontic appliance or removable partial denture with retention in the tooth where the lesion is located
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Composite resin restoration with Self Etch adhesive protocol and absence of sclerotic dentinThe adhesive system Single Bond Universal (3M Oral Care; Brazil) and a nanoparticulate composite resin Z350 XT (3M Oral Care; Brazil), shade A3B, will be the materials used in the restorative procedures. For the D-SE group, the universal adhesive system will be applied with a disposable microbrush, actively, for 20s and then a gentle stream of air will be used for 5s to solvent evaporation, followed by light curing for 10s using the Valo Cordless light curing (Ultradent Products Inc.), in Standard mode (1000mW /cm2). All groups will receive the restorations made following the incremental technique of insertion of composite resin (2mm per increment), which will be light cured according to the manufacturer's recommendations. | Procedure or surgery | D-SE |
| Composite resin restoration with Seletive enamel etch adhesive protocol and absence of sclerotic dentinThe adhesive system Single Bond Universal (3M Oral Care; Brazil) and a nanoparticulate composite resin Z350 XT (3M Oral Care; Brazil), shade A3B, will be the materials used in the restorative procedures. For the D-SELETIVE group a 37% phosphoric acid will be applied only at the enamel margin for 15s, then rinsed with water for 20s, and slightly dry. The universal adhesive system will be applied with a disposable microbrush, actively, for 20s and then a gentle stream of air will be used for 5s to solvent evaporation, followed by light curing for 10s using the Valo Cordless light curing (Ultradent Products Inc.), in Standard mode (1000mW /cm2). All groups will receive the restorations made following the incremental technique of insertion of composite resin (2mm per increment), which will be light cured according to the manufacturer's recommendations. | Procedure or surgery | D-SELETIVE |
| Composite resin restoration with Self Etch adhesive protocol and presence of sclerotic dentinThe adhesive system Single Bond Universal (3M Oral Care; Brazil) and a nanoparticulate composite resin Z350 XT (3M Oral Care; Brazil), shade A3B, will be the materials used in the restorative procedures. For the SD-SE group, the universal adhesive system will be applied with a disposable microbrush, actively, for 20s and then a gentle stream of air will be used for 5s to solvent evaporation, followed by light curing for 10s using the Valo Cordless light curing (Ultradent Products Inc.), in Standard mode (1000mW /cm2). All groups will receive the restorations made following the incremental technique of insertion of composite resin (2mm per increment), which will be light cured according to the manufacturer's recommendations. | Procedure or surgery | SD-SE |
| Composite resin restoration with Seletive enamel etch adhesive protocol and presence of sclerotic dentinThe adhesive system Single Bond Universal (3M Oral Care; Brazil) and a nanoparticulate composite resin Z350 XT (3M Oral Care; Brazil), shade A3B, will be the materials used in the restorative procedures. For the SD-SELETIVE group a 37% phosphoric acid will be applied only at the enamel margin for 15s, then rinsed with water for 20s, and slightly dry. The universal adhesive system will be applied with a disposable microbrush, actively, for 20s and then a gentle stream of air will be used for 5s to solvent evaporation, followed by light curing for 10s using the Valo Cordless light curing (Ultradent Products Inc.), in Standard mode (1000mW /cm2). All groups will receive the restorations made following the incremental technique of insertion of composite resin (2mm per increment), which will be light cured according to the manufacturer's recommendations. | Procedure or surgery | SD-SELETIVE |
Primary outcome
Retention
Time frame: 1 year
The restorations retention will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores: Alpha - retained Bravo - partially retained Charlie - restoration lost For evaluation of clinical performance, beta and charlie scores will be considered as failure.
Retention
Time frame: 2 years
The restorations retention will be evaluated according to the criteria established by the United States Public Health Service (USPHS), classifying them in the following scores: Alpha - retained Bravo - partially retained Charlie - restoration lost For evaluation of clinical performance, beta and charlie scores will be considered as failure.
4 secondary outcomes
Marginal adaptation
Time frame: 1 year
Marginal adaptation
Time frame: 2 years
Marginal staining
Time frame: 1 Year
Marginal staining
Time frame: 2 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecy M Silva, PhD principal investigator
Universidade Federal do Pará
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Composite resin restoration with Self Etch adhesive protocol and absence of sclerotic dentin, Composite resin restoration with Seletive enamel etch adhesive protocol and absence of sclerotic dentin and Composite resin restoration with Self Etch adhesive protocol and presence of sclerotic dentin in people with Sclerotic Dentine and Non Carious Cervical Lesion, run by Universidade Federal do Para at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cecy M Silva, PhD ((91)3201-7563 ext. 55, cecymsilva@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.